The long-awaited update to the Fertiliser Regulations, EC 2003/2003, has been released as a draft and there have been some changes. The changes are subtle and concern the analytical requirements. The draft of the new regulations is available here (Draft Fertiliser Regulations (June 2019)). There is no indication at the moment when this will come into force.
Annex I lists the Product Function Categories (PFCs) which products intended for registration are divided into and is related by their claimed function.
Annex II of the regulations gives the Component Material Categories (CMCs) which EU fertilising products shall solely consist. Please see over for lists of Annex I and Annex II categories.
Annex III outlines the information required on the label with respect to the PFC group.
For any product to be marketable in the EU it must pass the required analyses and standards and agree with the definitions given in the regulations. This is known as the Conformity Assessment which is described in Annex IV and is solely the obligation of the manufacturer. This information must be recorded in a dossier and maintained by a competent body. In order to achieve EC marking and be eligible for sale a Competent Authority must review and pass the dossier. This will be a Declaration of Conformity and covered by Annex V of the regulations.
For all but one PFC group, the fertilising products need only comply with the different requirements as set for the different PFCs and CMCs. There is an additional requirement for bio-stimulants. Any product being claimed to be a biostimulant must undergo efficacy trials. This is the only PFC which requests in the legislation that;
The plant biostimulant shall have the effects that are claimed on the label for the plants specified thereon.
This may be achieved by test methods or by field trials.
Further to these requirements all constituents must comply with REACH and CLP (Classification and labelling).
Cambridge Environmental Assessments (part of ADAS), can help you manage your substance through this new legislation and create a dossier for review. Our vast experience of REACH and regulatory affairs ensures a professional approach. Our office in Dublin allows us to obtain CE marking for your product via the Irish Notified Body, regardless of the outcome of Brexit.
If you have a biostimulant which requires field trials, our nationally acclaimed agricultural and horticultural trials expert colleagues in ADAS, will be able to conduct these.
For further information on the regulations or to discuss registering a fertiliser in the EU, please contact Neil Stearn (firstname.lastname@example.org) or Peter Godfrey (email@example.com).
For specific information on field trials, please contact Peter Berry (firstname.lastname@example.org) or Kate Storer (email@example.com).
Table of Categories for Fertilisers proposed under the Draft Fertiliser Regulations; (EU) 2019/1009
Annex I: Product Function Categories
Annex II: Component Material Categories
A. Organic fertiliser
I. Solid organic fertiliser
II. Liquid organic fertiliser
B. Organo-mineral fertiliser
I. Solid organo-mineral fertiliser
II. Liquid organo-mineral fertiliser
C. Inorganic fertiliser
Inorganic macronutrient fertiliser
(a) Solid inorganic macronutrient fertiliser
(i) Straight solid inorganic macronutrient fertiliser
(A) Straight solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content
(ii) Compound solid inorganic macronutrient fertiliser
(A) Compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content
(b) Liquid inorganic macronutrient fertiliser
(i) Straight liquid inorganic macronutrient fertiliser
(ii) Compound liquid inorganic macronutrient fertiliser
III. Inorganic micronutrient fertiliser
(a) Straight inorganic micronutrient fertiliser
(b) Compound inorganic micronutrient fertiliser
2. Liming material
3. Soil improver
A. Organic soil improver
B. Inorganic soil improver
4. Growing medium
A. Nitrification inhibitor
B. Denitrification inhibitor
C. Urease inhibitor
6. Plant biostimulant
A. Microbial plant biostimulant
B. Non-microbial plant biostimulant
7. Fertilising product blend
CMC 1: Virgin material substances and mixtures
CMC 2: Plants, plant parts or plant extracts
CMC 3: Compost
CMC 4: Fresh crop digestate
CMC 5: Digestate other than fresh crop digestate
CMC 6: Food industry by-products
CMC 7: Micro-organisms
CMC 8: Nutrient polymers
CMC 9: Polymers other than nutrient polymers
CMC 10: Derived products within the meaning of Regulation (EC) No 1069/2009, (health rules as regards animal by-products and derived products not intended for human consumption)
CMC 11: By-products within the meaning of Directive 2008/98/EC; (this sets the basic concepts and definitions related to waste management, such as definitions of waste, recycling, recovery.)